Antineoplaston Therapy in Treating Patients With Brain Tumors

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in adults with persistent or recurrent brain tumors.

OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Trea...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists
• • Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry
• • Tumor must be at least 5 mm
• • Ineligible for other Burzynski Research Institute, Inc. brain tumor protocols
• PATIENT CHARACTERISTICS:
• Age:
• • 18 and over
• Performance status:
• • Karnofsky 60-100%
• Life expectancy:
• • At least 2 months
• Hematopoietic:
• • Hemoglobin at least 9 g/dL
• • WBC at least 2,000/mm\^3
• • Platelet count at least 50,000/mm\^3
• Hepatic:
• • Bilirubin no greater than 2.5 mg/dL
• • SGOT/SGPT no greater than 5 times upper limit of normal
• • No hepatic failure
• Renal:
• • Creatinine no greater than 2.5 mg/dL
• • No history of renal conditions that contraindicate high dosages of sodium
• Cardiovascular:
• • No severe heart disease
• • No uncontrolled hypertension
• • No history of congestive heart failure
• • No history of other cardiovascular conditions that contraindicate high dosages of sodium
• Pulmonary:
• • No severe lung disease
• Other:
• • Not pregnant or nursing
• • Fertile patients must use effective contraception during and for 4 weeks after study participation
• • No serious active infections or fever
• • No other serious concurrent disease
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • At least 4 weeks since prior immunotherapy
• • No concurrent immunomodulating agents
• Chemotherapy:
• • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• • No concurrent antineoplastic agents
• Endocrine therapy:
• • Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry)
• Radiotherapy:
• • At least 8 weeks since prior radiotherapy
• Surgery:
• • Must recover from prior surgery
• Other:
• • Prior cytodifferentiating agent allowed
• • No prior antineoplaston therapy